Details for New Drug Application (NDA): 021356
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The generic ingredient in VIREAD is tenofovir disoproxil fumarate. There are forty-two drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.
Summary for 021356
Tradename: | VIREAD |
Applicant: | Gilead Sciences Inc |
Ingredient: | tenofovir disoproxil fumarate |
Patents: | 0 |
Pharmacology for NDA: 021356
Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 021356
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356 | NDA | Gilead Sciences, Inc. | 61958-0401 | 61958-0401-1 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (61958-0401-1) |
VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356 | NDA | Gilead Sciences, Inc. | 61958-0404 | 61958-0404-1 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (61958-0404-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
Approval Date: | Oct 26, 2001 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Jan 18, 2012 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Jan 18, 2012 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021356
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-001 | Oct 26, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-001 | Oct 26, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-004 | Jan 18, 2012 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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